Pacemate Flow Directed Thermal Dilution Catheter
FDA 510(k) K900317 · Elecath
510(k) numberK900317
Submission
- Device name
- Pacemate Flow Directed Thermal Dilution Catheter
- Applicant
- Elecath
Rahway, NJ, US - Received
- January 23, 1990
- Decision date
- June 22, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRB – Probe, Thermodilution
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1915
- Specialty
- Cardiovascular
Other 510(k)s with product code KRB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171620 | PiCCO CatheterKRB · Traditional | Pulsion Medical Systems SE | 02/21/2018SE |
| K100739 | Volumeview System, Models VLV520FT6R, VLV520FT8R, VLV520FT6R5KRB · Traditional | Edwards Lifesciences, LLC | 12/07/2010SE |
| K072364 | Pulsion Pulsiocath Thermodilution Catheters & AccessoriesKRB · Special | Pulsion Medical Systems AG | 09/19/2007SE |
| K020587 | Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing PV 4046KRB · Traditional | Pulsion Medical Systems AG | 05/23/2002SE |
| K991886 | Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion In-Line Injectate SensorKRB · Traditional | Pulsion Medical Systems, Inc. | 05/11/2000SE |
| K936182 | Critikit Plus in Line Room/Ice Temperature Injectate KitKRB · Traditional | Ohmeda Medical | 03/25/1994SE |
| K915627 | PaceviewKRB · Traditional | Micromedical Industries, Ltd. | 03/27/1992SE |
| K912172 | Safewedge(Tm) Relief Valve DeviceKRB · Traditional | Sunscope Intl., Inc. | 09/27/1991SE |
| K902627 | Interflo Medical Model Oxi/Co Fila. Thermo. Cath.KRB · Traditional | Biometric Research Institute, Inc. | 02/25/1991SE |
| K900710 | Interflo Medical Model F-1 Thermodilution CatheterKRB · Traditional | Intec Medical, Inc. | 10/19/1990SE |
Questions and answers
When was Pacemate Flow Directed Thermal Dilution Catheter cleared by the FDA?
Pacemate Flow Directed Thermal Dilution Catheter (K900317) received a 510(k) decision of Substantially Equivalent on June 22, 1990, 150 days after the submission was received.
What is the product code of K900317?
The FDA product code is KRB – Probe, Thermodilution, a Class II (moderate risk) device regulated under 21 CFR 870.1915.